AUDIENCE:Health Professional, Infectious Disease, Cardiology, Patient
ISSUE:FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection.
BACKGROUND:Fluoroquinolone antibiotics are approved to treat certain bacterial infections and have been used for more than 30 years. They work by killing or stopping the growth of bacteria that can cause illness. Without treatment, some infections can spread and lead to serious health problems (see List of Currently Available FDA-Approved Systemic Fluoroquinolones, available at Web Site).
Healthcare professionals should:
Taking moxifloxacin increases the risk that you will develop tendinitis (swelling of fibrous tissue that connects a bone to a muscle) or have a tendon rupture (tearing of fibrous tissue that connects a bone to a muscle) during your treatment or for up to several months afterward. These problems may affect tendons in your shoulder, your hand, the back of your ankle, or in other parts of your body. Tendinitis or tendon rupture may happen to people of any age, but the risk is highest in people over 60 years of age. Tell your doctor if you have or have ever had a kidney, heart, or lung transplant; kidney disease; a joint or tendon disorder such as rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function); or if you participate in regular physical activity. Tell your doctor and pharmacist if you are taking oral or injectable steroids such as dexamethasone, methylprednisolone (Medrol), or prednisone (Rayos). If you experience any of the following symptoms of tendinitis, stop taking moxifloxacin, rest, and call your doctor immediately: pain, swelling, tenderness, stiffness, or difficulty in moving a muscle. If you experience any of the following symptoms of tendon rupture, stop taking moxifloxacin and get emergency medical treatment: hearing or feeling a snap or pop in a tendon area, bruising after an injury to a tendon area, or inability to move to or bear weight on affected area.
Taking moxifloxacin may cause changes in sensation and nerve damage that may not go away even after you stop taking moxifloxacin. This damage may occur soon after you begin taking moxifloxacin. Tell your doctor if you have ever had peripheral neuropathy (a type of nerve damage that causes tingling, numbness, and pain in the hands and feet). If you experience any of the following symptoms, stop taking moxifloxacin and call your doctor immediately: numbness, tingling, pain, burning, or weakness in the arms or legs; or a change in your ability to feel light touch, vibrations, pain, heat, or cold.
Taking moxifloxacin may affect your brain or nervous system and cause serious side effects. This can occur after the first dose of moxifloxacin. Tell your doctor if you have or have ever had seizures, epilepsy, cerebral arteriosclerosis (narrowing of blood vessels in or near the brain that can lead to stroke or ministroke), stroke, changed brain structure, or kidney disease. If you experience any of the following symptoms, stop taking moxifloxacin and call your doctor immediately: seizures; tremors; dizziness; lightheadedness; headaches that won't go away (with or without blurred vision); difficulty falling asleep or staying asleep; nightmares; not trusting others or feeling that others want to hurt you; hallucinations (seeing things or hearing voices that do not exist); thoughts or actions toward hurting or killing yourself; memory problems; feeling restless, anxious, nervous, depressed, or confused, or other changes in your mood or behavior.
Taking moxifloxacin may worsen muscle weakness in people with myasthenia gravis (a disorder of the nervous system that causes muscle weakness) and cause severe difficulty breathing or death. Tell your doctor if you have myasthenia gravis. Your doctor may tell you not to take moxifloxacin. If you have myasthenia gravis and your doctor tells you that you should take moxifloxacin, call your doctor immediately if you experience muscle weakness or difficulty breathing during your treatment.
Talk to your doctor about the risks of taking moxifloxacin.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with moxifloxacin. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or check the manufacturer's website to obtain the Medication Guide.
Moxifloxacin is used to treat certain infections caused by bacteria such as pneumonia, and skin, and abdominal (stomach area) infections. Moxifloxacin is also used to prevent and treat plague (a serious infection that may be spread on purpose as part of a bioterror attack. Moxifloxacin may also be used to treat bronchitis or sinus infections but should not be used for these conditions if there are other treatment options available. Moxifloxacin is in a class of antibiotics called fluoroquinolones. It works by killing the bacteria that cause infections.
Antibiotics such as moxifloxacin will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Moxifloxacin comes as tablet to take by mouth. It is usually taken with or without food once a day for 5 to 21 days. The length of treatment depends on the type of infection being treated. Your doctor will tell you how long to take moxifloxacin. Take moxifloxacin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take moxifloxacin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
You should begin to feel better during the first few days of treatment with moxifloxacin. If your symptoms do not improve or if they get worse, call your doctor.
Take moxifloxacin until you finish the prescription, even if you feel better. Do not stop taking moxifloxacin without talking to your doctor unless you experience certain serious side effects listed in the IMPORTANT WARNING and SIDE EFFECTS sections. If you stop taking moxifloxacin too soon or if you skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.
Moxifloxacin is also sometimes used to treat tuberculosis (TB) ,certain sexually transmitted diseases, and endocarditis (infection of the heart lining and valves) when other medications cannot be used. Moxifloxacin also may be used to treat or prevent anthrax (a serious infection that may be spread on purpose as part of a bioterror attack) in people who may have been exposed to anthrax germs in the air if other medications are not available for this purpose. Moxifloxacin is also sometimes used to treat salmonella (an infection that causes severe diarrhea) and shigella (an infection that causes severe diarrhea) in patients who have human immunodeficiency virus (HIV) infection. Talk to your doctor about the risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking moxifloxacin,
Make sure you drink plenty of water or other fluids every day during your treatment with moxifloxacin.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Moxifloxacin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
If you experience any of the following symptoms, or any of the symptoms described in the IMPORTANT WARNING section, stop taking moxifloxacin and call your doctor immediately or get emergency medical help:
Moxifloxacin may cause problems with bones, joints, and tissues around joints in children. Moxifloxacin should not be given to children younger than 18 years old.
Moxifloxacin may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Web Site ) or by phone (1-800-332-1088).
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. Web Site
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( Web Site) for more information if you do not have access to a take-back program.
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to moxifloxacin. If you have diabetes, your doctor may ask you to check your blood sugar more often while taking moxifloxacin.
Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish taking moxifloxacin, call your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: January 15, 2019.